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Home › FDA recalls › Clonidine Transdermal System
CLASS II · ModerateFDA

Teva Pharmaceuticals USA, Inc recalls Clonidine Transdermal System

📅 Mar 19, 2026 · 📍 See notice
Recalling company
Teva Pharmaceuticals USA, Inc
Product
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
Reason
CGMP Deviations: use of an unapproved raw material
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 19, 2026
Reported
Apr 15, 2026
Distribution
Within U.S
Status
Ongoing
Quantity
113,943 Cartons
Lot / codes
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Company location
Parsippany, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0474-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0474-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.